Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Caroline Hroncich

Articles

Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards. 

Keeping it Clean: Biopharmaceutical Cleaning Validation

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval. 


Supreme Court Rules in Amgen v. Sandoz

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.  

FDA Asks Endo to Remove Opioid From Market

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar. 


Author | Caroline Hroncich